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Dear Si r
I have some quiries about the bionalaytical method validation.
If drug is Prodrug and it is conveting any form which active and
giving the action. at that time while doing the bioanalytical method
validation in plasma what subsatance we have to use.
Please suggest it
Thank you in Advanced
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The following message was posted to: PharmPK
Hi prashant
Without any doubt you have to estimate the therapeutically active moiety
in case of prodrugs example in case of nabumetone you have to estimate
6-MNA.
Hope this will be helpful
nageshwar
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Hi,
I would say you need to validate an assay monitoring
both prodrug and active component.
Xiaodong
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Hi
As per the regulatory requirement you need to analyse
the pharmacologically Active component( It doesn't
matter how much it is effective).
If you know the how much the parent compound is
bioavailable.
If it is not bioavalilable you can go ahead with the
Active substance. And you have to carryout the
specificity with respect to the the parent drug.
i this will help you.
others openions also needed.
Srinivas
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The following message was posted to: PharmPK
Dear Prashant,
I suppose prodrug approch is to improve the solubility
and absorption of the active moiety.
So we have to estimate the therapeutically active
moiety (parent compound)not the prodrug.
hope this will help
Raj
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The following message was posted to: PharmPK
Dear Prashant,
It's always good to know how much prodrug you have on board too. If the
prodrug is stable in plasma, you may be able to monitor both drug and
prodrug. Both will be relevant for filing. If this is just to see if
the prodrug approach did improve bio-availability, then you can forego
monitoring prodrug.
Good luck,
Joyce
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